NCT07278570

Brief Summary

The purpose of this research is to develop and test new Magnetic Resonance Imaging (MRI) methods that look at how muscles and tissues under the skin (myofascial tissues) move and respond to pressure. The investigators want to see how these tissues differ between healthy people and people with pain or injury, and how they change after hands-on treatment (Tuina therapy). The results will also be compared to a group that receives standard care without Tuina therapy. The main questions this study aims to answer are:

  1. 1.Can MR elastography (MRE) show changes in how the fascia and the layers between muscles move and stretch before and after manual therapy?
  2. 2.Do changes seen on MRE scans match changes in pain, function, and other symptoms reported by participants?
  3. 3.Can MRE measurements before treatment help predict which participants are most likely to improve with manual therapy?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Feb 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Feb 2026Aug 2027

First Submitted

Initial submission to the registry

December 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

December 4, 2025

Last Update Submit

February 2, 2026

Conditions

Myofascial Pain Syndrome - Lower BackMyofascial Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Pain, Enjoyment, and General Activity (PEG) score

    The Pain, Enjoyment, and General Activity (PEG) score is a three-item questionnaire asking individuals to rate their Pain, Enjoyment of life, and General activity on a scale of 0 to 10 over the past week. The PEG score is the average of the three responses, ranging from 0 to 10, with higher scores indicating more severe pain or interference with life

    Baseline, 1 day post-intervention, 3 weeks post-intervention

Study Arms (2)

Tuina + Usual Care

EXPERIMENTAL

Participants will receive Tuina therapy twice weekly for three consecutive weeks (a total of six sessions) in addition to usual care.

Other: Tuina treatmentOther: Usual care

Usual Care Only

ACTIVE COMPARATOR

Participants will receive usual care only for three weeks, no additional manual therapy will be provided.

Other: Usual care

Interventions

Tuina treatmentOTHER

Tuina is a manual therapy involving techniques that apply targeted shear and stretching forces along muscular and fascial planes. Tuina therapy will be administered to subjects twice weekly for three consecutive weeks (a total of six sessions). Each session will last 30-60 minutes and will be administered by licensed Tuina practitioners trained and credentialed at Mayo Clinic.

Tuina + Usual Care
Usual careOTHER

Standard care will be followed, including a patient education course, lifestyle guidance, cognitive-behavioral therapy, and home remedies.

Tuina + Usual CareUsual Care Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult males or females (age ≥ 18 years)
  • A history of chronic low back for at least 3 months. (Measured by patient history and physical exam)
  • A palpable taut band or nodule within the skeletal muscle
  • Hypersensitive tender spot within the taut band
  • Recognition of current pain complaint by pressure on the tender nodule/taut band
  • Painful limit to the full stretch range of motion

You may not qualify if:

  • Pregnancy or breastfeeding
  • Any contraindication to an MRI exam, or severe claustrophobia that would prevent safe completion of the scan
  • Previous therapy in the area to be treated within 3 months
  • Previous severe back injury (including fracture) or surgery
  • Any neurological conditions or active systemic disease (e.g. diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation/pain perception
  • Severe osteoarthritis
  • Skin injuries in the area to be treated
  • Inability to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

ENROLLING BY INVITATION

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Study Officials

  • Ziying Yin, Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa L Bush

CONTACT

507-266-1008Bush.Melissa1@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 12, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

February 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)